21 CFR Part 1316 — Administrative Functions, Practices, and Procedures
Subpart A — Administrative Inspections
- § 1316.01— Scope of subpart A.
- § 1316.02— Definitions.
- § 1316.03— Authority to make inspections.
- § 1316.04— Exclusion from inspection.
- § 1316.05— Entry.
- § 1316.06— Notice of inspection.
- § 1316.07— Requirement for administrative inspection warrant; exceptions.
- § 1316.08— Consent to inspection.
- § 1316.09— Application for administrative inspection warrant.
- § 1316.10— Administrative probable cause.
- § 1316.11— Execution of warrants.
- § 1316.12— Refusal to allow inspection with an administrative warrant.
- § 1316.13— Frequency of administrative inspections.
Subpart B — Protection of Researchers and Research Subjects
Subpart C — Enforcement Proceedings
Subpart D — Administrative Hearings
- § 1316.41— Scope of subpart D.
- § 1316.42— Definitions.
- § 1316.43— Information; special instructions.
- § 1316.44— Waiver or modification of rules.
- § 1316.45— Filings; address; hours.
- § 1316.46— Inspection of record.
- § 1316.47— Request for hearing; answer.
- § 1316.48— Notice of appearance.
- § 1316.49— Waiver of hearing.
- § 1316.50— Appearance; representation; authorization.
- § 1316.51— Conduct of hearing and parties; ex parte communications.
- § 1316.52— Presiding officer.
- § 1316.53— Time and place of hearing.
- § 1316.54— Prehearing conference.
- § 1316.55— Prehearing ruling.
- § 1316.56— Burden of proof.
- § 1316.57— Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
- § 1316.58— Summary of testimony; affidavits.
- § 1316.59— Submission and receipt of evidence.
- § 1316.60— Objections; offer of proof.
- § 1316.61— Exceptions to rulings.
- § 1316.62— Interlocutory appeals from rulings of the presiding officer.
- § 1316.63— Official transcript; index; corrections.
- § 1316.64— Proposed findings of fact and conclusions of law.
- § 1316.65— Report and record.
- § 1316.66— Exceptions.
- § 1316.67— Final order.
- § 1316.68— Copies of petitions for judicial review.